Radial artery compression device

ABSTRACT

A radial artery compression device configured to be secured to a wrist or other portion of a patient to provide adjustable and consistent compression pressure in the area of a radial artery access site or other physiological portion of a patient to achieve hemostasis either during or after a medical procedure such as a percutaneous coronary procedure. The radial artery compression device includes a rotatable member and a compression pad adapted such that rotation of the rotatable member does not affect the rotational orientation of the compression pad. According to one embodiment of the present invention, a single rotation of the rotatable member results in complete extension or retraction of the radial artery compression device. According to another embodiment of the present invention, the rotation of the rotatable member results in a compounding of the extension or retraction of the compression pad relative to the body of the radial artery compression device.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present disclosure relates to a radial artery compression device. Inmore particular, the present disclosure relates to a radial arterycompression device configured to provide an adjustable level ofcompression pressure on the radial artery to achieve hemostasis at, orin the area of, a vascular access site.

2. Relevant Technology

Medical advancements have resulted in the ability to diagnose and treatcoronary artery disease using vascular delivery apparatus andtechniques. One advantage of coronary procedures utilizing vasculardelivery is that a practitioner can access a desired position within thepatient's body without administering general anesthetic or requiringhighly invasive surgery. During a typical procedure, a sheath having ahaemostatic valve is utilized to access a peripheral artery utilizingthe administration of a local anesthetic at the vascular access site. Apre-shaped catheter is then introduced into the patient's vasculaturethrough the sheath. The catheter can then be advanced to the ostium ofthe relevant coronary artery or to another desired location within thepatient. The catheter enables delivery of medical instruments, medicinesor fluids such as radiography contrast medium, angioplasty wires,balloons, and stents. During or after completion of the procedure, thesheath and catheter are removed and hemostasis can be achieved by manualcompression, suturing the access site, or by utilizing another directrepair procedure.

Often these percutaneous coronary diagnostic and interventionalprocedures are accomplished through the radial artery of a patient.Radial artery access has the potential advantages of reduced access sitecomplications, rapid patient mobilization, and reduced costs. Therelatively superficial position of the distal radial artery enablesdirect application of compression to the artery to achieve and maintainhemostasis during a procedure. Additionally the radial artery allowsquick and direct closure at the catheter access site as soon as thearterial catheter has been removed at the end of the procedure.

As with any arterial puncture, achieving hemostasis during and/or aftera procedure can be challenging. Typically the access site, or opening,in the artery is created utilizing a micropuncture apparatus, dilator orcan even be formed utilizing a single straight incision to form a slitin the artery. The pulsatile nature of arterial blood flow may presentchallenges to achieving hemostasis at the access site. As a result ofthis and other factors, during the course of the procedure, blood mayleak through the access site and around the outside diameter of thesheath or catheter. Existing devices are not adapted to provide desiredand/or adjustable compression to the radial artery at the vascularaccess site during the course of a procedure.

When the procedure has been completed, typically the catheter is removedand the practitioner or medical professional will apply pressure at thevascular access site to achieve hemostasis and effectuate closure of thevascular access site. One technique for achieving hemostasis is to applypressure at, or at a point slightly upstream, of the vascular accesssite. Typically, continuous pressure is necessary to stop bleeding andachieve hemostasis at the access site. While the applied pressure shouldremain relatively constant, there are advantages to applying a higherlevel of compression pressure at the beginning of the compression periodand then reducing the level of compression pressure after a determinedamount of time has elapsed. By gradually reducing the compressionpressurization during the compression period, while continuallymaintaining at least a threshold level of compression, blood can beginto flow through the artery at a reduced pressure, providing nutrientrich blood to the tissue downstream from the access site. Blood flowingthrough the artery can then hasten clotting to enable hemostasis withoutapplication of ongoing compression. Not only can this provide improvedclosure, but also can improve the relative comfort of the patient.

Compression is typically applied to an access site by a nurse or otherpractitioner by manually holding a dressing at the access site. Althoughemploying a practitioner to provide compression permits the gradualreduction of pressurization at the access site, it can also be a costlyuse of practitioner time. Alternative existing radial artery compressiontechniques which do not require the ongoing manual application ofpressure by the practitioner may employ tape or a compression bandage atthe vascular access site. These devices and techniques, while allowingthe practitioner to attend to other matters, can render it difficult orimpractical to adjust the compression pressure while maintainingcontinuous pressure. As a result, the tape or compression bandages mayend up being positioned around the access site without being loosened oradjusted until they are removed. Additionally, the compression providedby such techniques can be poorly applied, insufficient to provide properpressurization and/or may be poorly tailored for the exigencies of theparticular procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an improved radial artery compressiondevice according to one aspect of the present invention.

FIG. 2A is a perspective view a radial artery compression device of FIG.1 illustrating use of the device on a patient.

FIG. 2B is a perspective view of a radial artery compression deviceillustrating the manner in which the radial artery compression devicecan secure a catheter within a patient's radial artery according to oneaspect of the present invention.

FIG. 2C is a perspective view of a radial artery compression device ofFIG. 1 illustrating retraction of a compression pad of the radial arterycompression device.

FIG. 3 is an exploded view of a radial artery compression device of FIG.1 according to one aspect of the present invention.

FIG. 4A is side view of a radial compression device of FIG. 1illustrating the compression pad in an extended position according toone aspect of the present invention.

FIG. 4B is a side view of a radial compression device of FIG. 4Aillustrating the compression pad in the retracted position according toone aspect of the present invention.

FIG. 5 is a bottom perspective view of a radial artery compressiondevice of FIG. 1 illustrating the ratcheting mechanism of the radialartery compression device according to one aspect of the presentinvention.

FIG. 6A is a cross-sectional view of a radial artery compression deviceof FIG. 1 illustrating the compression pad in an extended positionaccording to one aspect of the present invention.

FIG. 6B is a cross-sectional view of a radial artery compression deviceof FIG. 6A illustrating the compression pad in a retracted positionaccording to one aspect of the present invention.

FIG. 7 is a cross-sectional view of a radial artery compression deviceillustrating the manner in which the compression pad secures thecatheter within the radial artery of a patient according to one aspectof the present invention.

FIG. 8 is a top perspective view of a radial artery compression deviceaccording to one aspect of the present invention.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to an improved radial arterycompression device. The radial artery compression device is adapted toallow a user to provide varying degrees of pressurization against apatient's radial artery in order to maintain a desired degree ofhemostasis at a percutaneous catheter access site. The radial arterycompression device includes a rotatable member and a compression pad.The rotatable member allows a practitioner to actuate the compressionpad to provide an increased or decreased amount of pressurizationagainst a patient's radial artery.

According to one aspect of the present invention, the radial arterycompression device can be secured to a patient's wrist utilizing astrap, wrist band or other mechanism. Upon actuation of the rotatablemember, the compression pad can be extended away from a body of theradial artery compression device. When the compression pad is extendedaway from the body of the radial artery compression device an increasedamount of pressurization is provided against the radial artery. In theevent that a catheter is positioned within the radial artery, theconfiguration of the surface of the compression pad secures the wall ofthe radial artery against the outside diameter of the catheterpositioned therein. In this manner, the radial artery compression devicecan maintain hemostasis of the radial artery relative to the catheter.In other words, a practitioner can actuate the radial artery compressiondevice to secure a catheter within a patient's radial artery whileproviding a desired degree of hemostasis at the percutaneous accesssite. As a result, the radial artery compression device allows thepractitioner to turn his/her attention to other aspects of the procedurebeing done.

Once the practitioner has substantially completed a procedure and isready to remove the catheter from the patient's radial artery, thepractitioner can easily retract the compression pad relative to the bodyof the radial artery compression device. Retraction of the compressionpad relative to the body of the radial artery compression device removesthe compression pressurization which helps to maintain the catheterwithin the patient's radial artery. As a result, the practitioner canremove the catheter from within the patient's radial artery.

The configuration of the radial artery compression device allows thepractitioner to actuate the rotatable member utilizing a single hand,thus freeing the other hand of the practitioner to perform other aspectsof a procedure. For example, the practitioner can hold a catheter withina percutaneous access site in the patient's wrist while actuating therotatable member to extend the compression pad and secure the catheterwithin the patient's radial artery. Alternatively, the practitioner canslowly deactuate the rotatable member of the radial artery compressiondevice in order to withdraw the compression pad relative to the body ofthe radial artery compression device and remove the catheter from thepatient's wrist.

According to one aspect of the present invention, the radial arterycompression device includes a threaded shaft which is secured to therotatable member. The threaded shaft threadably engages the body of theradial artery compression device such that actuation of the threadedshaft results in a first amount of movement of the threaded shaft. Asecondary shaft is provided in threaded communication with the threadedshaft which is secured to the rotatable member. In this manner, acompound threading action is provided upon rotation of the rotatablemember. In other words, when the rotatable member is rotated by theuser, a first amount of axial displacement is provided by the threadedshaft. A second amount of axial displacement is provided in addition tothe first amount of axial displacement by the secondary threaded shaft.In this manner, a desired degree of rotation of the rotatable memberprovides an increased amount of axial displacement of the compressionpad relative to the body of the radial artery compression device.

According to another aspect of the present invention, a body of theradial artery compression device provides a structure upon which theother components of the radial artery compression device are secured. Arotatable member is provided on the upward facing portion of the bodyand the compression pad is located on the downward facing portion of thebody of the radial artery compression device. The rotatable memberincludes a threaded shaft which is threaded through the body of theradial artery compression device. The body of the radial arterycompression device includes a threaded aperture which threadably engagesthe threaded shaft of the rotatable member. In this manner, rotation ofthe rotatable member and the cooperative engagement of the thread shaftof the rotatable member and the threaded aperture of the body results inaxial displacement of both the rotatable member and the threaded shaft.A secondary threaded shaft is provided in connection with thecompression pad. As a result, when a user rotates the rotatable member,the threaded interaction between the threaded shaft of the rotatablemember and the threaded shaft of the compression pad results in axialdisplacement of both the compression pad and the secondary threadedshaft relative to the rotatable member. As a result, a compoundingeffect is effectuated in which rotation of the rotatable member providesa greater amount of axial displacement than would be provided bycooperative engagement of the primary threaded shaft with the threadedaperture of the body of the radial artery compression device.

According to one aspect of the present invention, a threaded shaft isformed of rigid material and is disposed through the body of the radialartery compression device. The threaded shaft is positioned between therotatable member and the compression pad of the radial arterycompression device. The threaded shaft threadably engages the bodyallowing movement of the rotatable member relative to the body. A secondshaft formed of rigid material is also provided. The second shaft ispositioned between the rotatable member and the compression pad. Thesecond shaft threadably engages the first shaft such that the threadedengagement between the first shaft and the second shaft results inmovement of the compression pad with respect to the body as therotatable member is rotated relative to the body. As a result, rotationof the rotatable member in a first direction is configured to increasethe amount of compression applied to the radial artery by thecompression pad. The rotation of the rotatable member in a seconddirection is adapted to decrease the amount of compression applied tothe radial artery by the compression pad.

According to one aspect of the present invention, the configuration ofthe rotatable member and compression pad is such that inadvertentrotational movement of the compression pad is prevented. For example, inone embodiment the first threaded shaft and the second threaded shaftengage one another such that the axial movement of the compression padrelative to the body of the radial artery compression device does notresult in rotational movement of the compression pad. In anotherembodiment, body engagement posts are secured relative to thecompression pad to minimize or prevent rotational movement of thecompression pad relative to the body of the radial artery compressiondevice.

Minimizing rotational movement of the compression pad can be desirablefor a variety of reasons. For example, the compression pad can include anotch or step which is desired to be aligned with the radial artery orcatheter. The compression pad can provide a desired curvature whichconforms to the outside diameter of the catheter and/or the structure ofthe radial artery. By controlling rotational movement of the compressionpad, the desired alignment of the features of the compression pad can bemaintained without additional user attention or manipulation.Additionally, the first and second sides of the contact surface of thecompression pad can be adapted to conform to the physiological featuresof a patient's wrist to provide a desired amount of contact between thecompression pad and the patient's wrist when the desired rotationalalignment of the compression pad is maintained. As a result, maintainingthe rotational alignment of the compression pad of the radial arterycompression device throughout the course of the procedure, despiterotation of the rotatable member during the procedure, can be importantto maintain desired operability of the radial artery compression device.

According to another aspect of the present invention, the radial arterycompression device includes ratchet engagement members. The ratchetengagement members permit rotation of the rotatable member in a firstdirection without additional manipulation by the user. However, theratchet engagement members prevent rotation of the rotatable member in asecond direction without first releasing the ratchet engagement membersrelative to the rotatable member. For example, in one embodiment, theuser is allowed to rotate the rotatable member in a clockwise directionto extend the compression pad and thus apply an increased degree ofcompression on the radial artery. However, the user is not allowed torotate the rotatable member in a counter-clockwise direction to retractthe compression pad and result in a lesser amount of compression beingapplied to the radial artery. As a result, inadvertent or undesiredreleasing of the pressurization provided by the compression pad relativeto the patient's wrist, radial artery, or catheter is controlled, thusensuring desired compression on the patient's wrist during the course ofthe procedure. When the user desires to lessen the amount ofpressurization on the patient's radial artery or to remove a catheterfrom the patient's artery, the user first disengages the ratchetmechanism to allow rotation of the rotatable member in the secondrotational direction.

According to one embodiment of the present invention, the ratchetmechanism is positioned on an interior diameter of the rotatable member.According to another embodiment of the present invention, the ratchetengagement or disengagement members are buttons positioned on one orboth sides of the rotatable member which are depressed by the user torelease the engagement of the ratchet. According to yet anotherembodiment, the ratchet engagement member includes one or more rampswhich permit rotation of the rotatable member in a first position whilepreventing or minimizing rotation of the rotatable member in a seconddirection.

DETAILED DESCRIPTION

FIG. 1 is a perspective view of a radial artery compression device 10according to one embodiment of the present invention. Radial arterycompression device 10 is adapted to allow a user to provide varyingdegrees of pressurization against a patient's radial artery or otherposition in a patient's vasculature to maintain a desired degree ofhemostasis at a percutaneous access site. In the illustrated embodiment,radial artery compression device 10 comprises a rotatable member 12, abody 20, wrist straps securement members 24 a, b, a compression pad 30,and a threaded shaft 50.

Body 20 is adapted to provide a framework upon which the othercomponents of the radial artery compression device 10 can be positioned.In the illustrated embodiment rotatable member 12 and compression pad 30are positioned on alternative sides of body 20. Compression pad 30 ispositioned on the underside of body 20 such as to be positioned adjacenta patient's skin or other desired target of a pressurization procedure.Rotatable member 12 is positioned on the upper side of body 20. Thepositioning of rotatable member 12 relative to body 20 allows apractitioner to rotate rotatable member 12 in a desired manner so as toallow for proper actuation of radial artery compression device 10.

In the illustrated embodiment, rotatable member 12 is adapted to allow apractitioner to actuate or deactuate radial artery compression device10. Additionally, rotatable member 12 allows a practitioner toincrementally increase or decrease the amount of pressurization providedby compression pad 30 throughout the course of a procedure. Rotatablemember 12 comprises a handle member 14, a sidewall 16, a central void17, an upper face 18, and indicia 19 a-d. In the illustrated embodiment,a handle member 14 is provided to allow a user to grasp rotatable member12 and to rotate rotatable member 12 in a desired manner. Handle member14 has an arcuate S-curve type shape which provides an ergonomic anddesired grip. The shape of handle member 14 allows a user to place athumb and index finger on alternative sides of handle member 14 to twistrotatable member 12 in either a clockwise or counter-clockwiserotational direction. In this manner, an ergonomic and easy to graspconfiguration is provided by handle member 14.

Central void 17 forms a circular recessed region in the center ofrotatable member 12. Central void 17 is intersected by the arcuateconfiguration of handle member 14. In other words, handle member 14extends from one lateral side of central void 17 to the opposing lateralside of central void 17. In this manner, a recess is provided relativeto upper face 18 of rotatable member 12. Handle member 14 can extendfrom an elevation which extends above upper face 18 to a position withincentral void 17 which extends below upper face 18. The resultanthemispherical type voids on either lateral side of handle member 14created by the juxtaposition of central void 17 and handle member 14 canreceive the finger or thumb to grasp handle member 14 and cause rotationof rotatable member 12.

Upper face 18 in sidewall 16 forms the outer periphery of rotatablemember 12. Sidewall 16 extends a determined amount in an upwarddirection such that a user can grasp the outer facing surface ofsidewall 16 and rotate rotatable member 12. Additionally, sidewall 16provides a thickness or overall elevational dimension to the body ofrotatable member 12. Upper face 18 is positioned so as to face away fromthe body 20 of radial artery compression device 10. Upper face 18includes a plurality of indicia 19 a-d which provide the user anindicator of the rotational position of rotatable member 12. This allowsa user to ascertain and perceive not only the current rotationalposition of rotatable member 12 but to ascertain the current rotationalposition relative to other rotational positions of rotatable member 12.

In the illustrated embodiment, the configuration of rotatable member 12is such that a single rotation of rotatable member 12 causes extensionof compression pad 30 through a range of at least half of the totalpossible axial movement of compression pad 30. As a result, when theuser rotates rotatable member 12, a single rotation of rotatable member12 will cause a substantial amount of movement of compression paid 30.Similarly, a single full rotation of rotatable member 12 results in asubstantial pressurization increase by compression pad 30 on the radialartery or other physiological feature of a patient. As a result, when afirst indicia is moved from one rotational position to a secondrotational position, a user can ascertain the approximate amount ofextension of compression pad 30 relative to body 20.

In the illustrated embodiment indicia 19 a is a numeric indicia “1”,indicia 19 b is a numeric indicia “2”, indicia 19 c is a numeric indicia“3” (see FIG. 2B), and indicia 19 d is a numeric indicia “4”. In theillustrated embodiment indicia 19 a is adjacent to a ratchet engagementmember 26 a and indicia 19 d is adjacent to a ratchet engagement member26 b. When rotatable member 12 is rotated such that indicia 19 a ispositioned adjacent to ratchet engagement member 26 b instead of beingpositioned adjacent to ratchet engagement member 26 a, a practitionercan perceive that compression pad 30 has been extended a predeterminedamount and a desired amount of pressurization is provided against apatient's wrist or other physiological feature. According to oneembodiment of the present invention, a single rotation of rotatablemember 12 results in a complete and full extension of compression pad 30relative to body 20. In other words, a single rotation of rotatablemember 12 moves compression pad 30 from a position in which compressionpad 30 is fully retracted to a position of in which compression pad 30is fully extended.

Wrist strap securement members 24 a, b are integrally coupled to body 20of radial artery compression device 10. Wrist strap securement members24 a, b are positioned on opposing lateral sides of body 20. Wrist strapsecurement members 24 a, b include a loop or central bore which permitsthe threading of a strap, or other securement member which can be placedaround a patient's wrist to secure radial artery compression device 10relative to the wrist or other physiological feature of a patient.

Ratchet engagement members 26 a, b are also positioned on opposing sidesof body 20. Ratchet engagement members 26 a, b project from theunderside of rotatable member 12 and extend in an upward directionadjacent the sidewall 16 of rotatable member 12. Ratchet engagementmembers 26 a, b are adapted to be grasped by the user and pushed inwardin the direction of one another. Actuation of ratchet engagement members26 a, b disengages a ratchet mechanism associated with rotatable member12 allowing rotation of rotatable member 12 in both a first directionand a second direction. In one embodiment, a user releases rotatablemember 12 by biasing ratchet engagement member 26 a toward ratchetengagement member 26 b and by biasing ratchet engagement member 26 b inthe direction of ratchet engagement member 26 a. Biasing ratchetengagement members 26 a, b in the direction of one another effectivelyreduces the spatial distance between ratchet engagement member 26 a andratchet engagement member 26 b. In this manner, an internal ratchetcomponent which engages a component of rotatable member 12 is releasedallowing movement of rotatable member 12 in one or both of a clockwiseand counter-clockwise direction.

According to one aspect of the present invention, the practitioner isallowed to rotate rotatable member 12 in a first rotational direction toextend compression pad 30 without actuating ratchet engagement members26 a, b. The ratchet mechanism associated with radial artery compressiondevice 10 prevents rotation of rotatable member 12 in a second directioneffectively securing compression pad 30 in a desired extended position.In this manner, during the course of a procedure a desired amount ofcompression can be consistently provided by radial artery compressiondevice 10 without requiring the ongoing attention of the practitioner.Additionally, the practitioner can simply and quickly change the amountof compression provided by the radial artery compression device 10 bysimple actuation of rotatable member 12.

In the event the practitioner desires to retract compression pad 30relative to body 20 or otherwise lessen the amount of compressionprovided by radial artery compression device 10 relative to the patient,the user simply compresses ratchet engagement members 26 a, b relativeto one another. When ratchet engagement members 26 a, b are compressed,the engagement of rotatable member 12 is released and rotation ofrotatable member 12 in a reverse direction is permitted. Rotation ofrotatable member 12 in a reverse direction allows retraction ofcompression pad 30 relative to body 20.

In the illustrated embodiment, a threaded shaft 50 is depicted. Threadedshaft 50 is actuated by rotation of rotatable member 12. When a userrotates rotatable member 12, threaded shaft 50 engages threaded membersor other components of radial artery compression device 10 causing axialmovement of compression pad 30 relative to body 20. For example, whenrotatable member 12 is rotated in a first direction, the threaded shaftcan engage a threaded member of body 20 resulting in extension ofcompression pad 30 relative to body 20. In other words, when rotatablemember 12 is rotated in a first direction, compression pad 30 moves awayfrom body 20. When rotatable member 12 is rotated in a second direction,the cooperative engagement of threaded shaft 50 with the threadedcomponent of body 20 results in retraction of compression pad 30relative to body 20. In other words, the distance between compressionpad 30 and body 20 is decreased when rotatable member 12 is rotated in asecond direction.

Compression pad 30 includes a first portion 32, a second portion 34, anotch 36, and a step 38. First portion 32 is positioned on one lateralside of step 38. Second portion 34 is position on the opposing side ofcompression pad 30. Notch 36 provides a cutout in the otherwise circularradius of compression pad 30. Notch 36 provides a pie shaped or angularcutout which is wider at the radius of compression pad 30 and graduallynarrows to a point as the notch approaches the middle of compression pad30. The configuration of notch 36 is such that the point of notch 36 isaligned with step 38. Step 38 runs from one lateral side of compressionpad 30 to the opposing lateral side of compression pad 30.

In the illustrated embodiment, compression pad 30 includes a firstportion 32 and a second portion 34. First portion 32 has a differentelevation than second portion 34. For example, in the illustratedembodiment first portion 32 has a higher elevation such that thesidewall of compression pad 30 associated with first portion 32 has aminimal height. In contrast, second portion 34 has a lower elevationsuch that the sidewall of compression pad 30 associated with secondportion 34 has a greater height than the sidewall of compression padassociated with first portion 32. Additionally, the distance between thecontact surface of second portion 34 is further away from the uppersurface of compression pad 30 than that of first portion 32.

The different elevational positions of first portion 32 and secondportion 34 is adapted to conform to the physiological features on theunderside of a patient's wrist. For example, the outside of a patient'swrist is somewhat depressed from the more central portion of a patient'swrist. As a result, the different elevational surfaces of compressionpad 30 provided by first portion 32 and section portion 34 provide abetter overall contact with the portions of the patient's wrist oneither side of the patient's radial artery.

Step 38 provides a transition from first portion 32 to second portion34. According to one embodiment of the present invention, step 38 has acurvilinear, arcuate, or radial dimension which can more closelyapproximate the outside diameter of a catheter which may be positionedwithin a patient's radial artery. Notch 36 provides desired compressionaround a percutaneous catheter access point such that the catheter ismaintained in desired hemostasis within the patient's radial artery.

FIG. 2A is a perspective of radial artery compression device 10 of FIG.1 according to one embodiment of the present invention. In theillustrated embodiment, radial artery compression device 10 has beensecured to a patient's wrist 41. A wrist strap 42 circumscribes apatient's wrist 41 and is secured to wrist strap securement members 24a, b. Additionally, radial artery compression device 10 is secured tothe underside of patient's wrist 42. Radial artery compression device 10is positioned such that compression pad 30 is adapted to be in contactwith a lateral side of patient's wrist 41. Radial artery compressiondevice 10 is positioned on the lateral side of patient's wrist 41adjacent patient's thumb 46. This is due to the fact that the radialartery is positioned laterally within the patient's wrist on the samelateral side of the patient's wrist 41 as the patient's thumb 46.

In the illustrated embodiment, compression pad 30 is positioned suchthat it is in a retracted position relative to body 20. As a result, aminimal amount of compression is provided on the patient's wrist. Acatheter 40 is positioned within the patient's radial artery.Compression pad 30 is positioned over catheter 40 such that notch 36accommodates the portion of catheter 40 extending from patient's wrist41. The juxtaposition of compression 30 relative to catheter 40 providesa desired amount of compression at the radial artery access site inwhich catheter 40 is entering the patient's radial artery. As will beappreciated by those skilled in the art, catheter 40 will typically bethreaded from the thumb side of the patient's wrist and extend upwardinto the patient's arm. Additionally, notch 36 will be positioned on thehand side of the radial artery compression device 10. In the illustratedembodiment, a practitioner is holding catheter 40 to maintain theposition of catheter 40 within the patient's radial artery prior to fullactuation of radial artery compression device 10. In other words, in theillustrated embodiment radial artery compression device 10 has beensecured to the patient's wrist, however rotatable member 12 has not yetbeen fully actuated. While radial artery compression device 10 has beensecured to the patient's wrist, compression pad 30 has not been extendedto a position to secure catheter 40 within the patient's radial artery.Once the radial artery compression device 10 has been secured to thepatient's wrist 41 utilizing wrist strap 42, the practitioner canactuate rotatable member 12. Actuation of rotatable member 12 allows thepractitioner to effectuate desired axial movement of compression pad 30so as to cause desired compression of catheter 40 within the patient'sradial artery.

The configuration of radial artery compression device 10 allows apractitioner to actuate rotatable member 12 utilizing a single hand. Asa result, the practitioner can hold catheter 40 in one hand to maintainthe desired position of the catheter 40 within the patient's radialartery while simultaneously actuating rotatable member 12 with thepractitioner's other hand. As a result, radial artery compression device10 allows for a single handed actuation and securement of a catheterwithin a patient's vasculature while permitting desired and oftenadvantageous use of the practitioner's other hand in other aspects ofthe procedure.

FIG. 2B is a perspective view of the radial artery compression device 10of FIG. 2A. In the illustrated embodiment, rotational arrows 2 b-2 b areillustrated. Rotational arrows 2 b-2 b are indicative of a clockwiserotational direction of rotatable member 12. Rotation of rotatablemember 12 in the clockwise rotational position as indicated byrotational arrow 2 b-2 b causes extension of compression pad 30 fromwithin recess 22 of body 20. Recess 22 is adapted to accommodatecompression pad 30 when compression pad 30 is in a fully retractedposition.

Catheter 40 is positioned within a percutaneous access site allowing thethreading of catheter 40 into the patient's radial artery. As previouslydiscussed, catheter 40 will typically be threaded into the patient'sartery from the hand side of the wrist and extend in the direction ofthe elbow of the patient. Once a practitioner has threaded catheter 40to a desired position within the patient's radial artery, thepractitioner can grasp a handle member 14 or other portion of rotatablemember 12 and rotate rotatable member 12 in a clockwise rotationaldirection. As the practitioner rotates rotatable member 12 in aclockwise rotational direction, threads of threaded shaft 50cooperatively engage other components of radial artery compressiondevice 10 resulting in axial movement of compression pad 30. As thepractitioner continues to rotate rotatable member 12, compression pad 30moves from within recess 22 of body 20 such that the distance betweencompression pad 30 and body 20 begins to increase. As a result,compression pad 30 begins to exert increasing pressure on the patient'swrist 41. The portion of catheter 40 positioned within the patient'swrist is contacted by step 38 (see FIG. 1) on the on the underside ofcompression pad 30. In particular, due to the threading of catheter 40beneath compression pad 30, pressure begins to be exerted on both theradial artery and in particular on the portion of the radial artery inwhich catheter 40 is positioned. In this manner, when a desired degreeof compression is provided by compression pad 30, the configuration ofcompression pad 30 effectively seals catheter 40 within the radialartery of the patient. Additionally, the flow of blood from thepercutaneous access site is stopped. As a result, radial arterycompression device 10 provides a consistent and desired degree ofcompression on the percutaneous access site in the patient's wristwithout requiring ongoing attention or manual compression by thepractitioner. In other words, once the practitioner has fully actuatedrotatable member 12, compression pad 30 will hold catheter 40 in placewithin the patient's vasculature while also minimizing or preventingbleeding at the catheter access site. This allows the practitioner toturn her/his attention to other aspects of the procedure to beperformed.

In the illustrated embodiment, ratchet engagement members 26 a, b, havenot been depressed. As a result, rotational movement in acounter-clockwise direction, or a direction opposite to the rotationalarrows 2 b-2 b is prevented. As a result, inadvertent releasing of thepressure provided by compression pad 30 is prevented. In the illustratedembodiment, the cooperative interaction between threaded shaft 50, body20, and rotatable member 12 results in little or no rotational movementof compression pad 30 pursuant to rotation of rotatable member 12. Inother words, as the user rotates rotatable member 12, the rotationalposition of notch 36 remains unchanged. As a result, a user can alignnotch 36 with catheter 40 and step 38 (see FIG. 1) along the patient'sradial artery. Once the components of compression pad 30 are properlyaligned, the practitioner can actuate rotatable member 12 without therisk that compression pad 30, and in particular notch 36 and step 38(see FIG. 1), will remain in their correct rotational orientationrelative to catheter 40 as the practitioner rotates rotatable member 12.For example, a user may position a notch of compression pad 30 overcatheter 40. Additionally, step 38 (see FIG. 1) of compression pad 30may be aligned over the portion of the radial artery in which catheter40 extends. As the user rotates rotatable member 12, the positioning ofnotch 36 relative to the other components of radial artery compressiondevice 10 remain unchanged.

In the illustrated embodiment, notch 36 is positioned at a rotationalposition which is approximately half way between ratchet engagementmembers 26 a, b. Additionally, notch 36 is positioned approximately halfway between wrist strap securement members 24 a, b. As the user beginsto rotate rotatable member 12, the rotational position of notch 36remains unchanged relative to the components of body 20. As a result,during rotation of rotatable member 12, notch 36 remains positionedapproximately half way between ratchet members 26 a, b and wrist strapsecurement members 24 a, b. This facilitates desired alignment andoperation of the components of radial artery compression device 10throughout the course of the compression procedure.

As will be appreciated by those skilled in the art, a variety of typesand components of radial artery compression devices can be providedwithout departing from the scope and spirit of the present invention.For example, according to one embodiment of the present invention, arotatable member which rotates in a counter-clockwise direction toactuate the compression pad is utilized. According to another embodimentof the present invention, a handle component, knob, or other actuationmember having a configuration which is different than the rotatablemember is utilized. According to another embodiment of the presentinvention, the compression pad is actuated utilizing a motion other thanrotation. According to another embodiment of the present invention,actuation or reverse actuation of the rotatable member requiresdisengagement of a ratchet engagement member or other rotationalsecurement component. In yet another embodiment, a compression pad has acontact surface or configuration that is different from that depicted inFIGS. 1-2B. For example, according to one embodiment of the presentinvention, the compression pad may have a soft or pliable component. Inanother embodiment, the compression pad may not include a notch portion.In yet another embodiment, the contact surface of the compression padmay have a somewhat flat or curved configuration rather than havingfirst and second elevational components.

FIG. 2C is a perspective view of the radial artery compression device ofFIG. 2A. In the illustrated embodiment, the practitioner is graspingratchet engagement members 26 a, b (see also FIG. 2B) by urging ratchetengagement members 26 a, b (see also FIG. 2B) toward one another. Inthis manner, an internal ratchet member which prevents counter-clockwiserotational movement of rotatable member 12 is released. Once the ratchetengagement members 26 a, b (see also FIG. 2B) are compressed, thepractitioner can rot ate rotatable member 12 in a counter-clockwisedirection indicated by directional arrows 2 c-2 c. As the practitionerrotates rotatable member 12 in a counter-clockwise direction,compression pad 30 is retracted back in the direction of body 20. Inother words, as rotatable member 12 is rotated in the counter-clockwisedirection indicated by rotational arrows 2 c-2 c, the distance betweenbody 20 and compression pad 30 lessens until compression pad 30 is fullyretracted into a recess of body 20.

As the amount of force provided by compression pad 30 decreases, thesecurement of catheter 40 within the patient's wrist is lessened. Oncethe compression provided by compression pad 30 is diminished to adesired extent, a practitioner can grasp catheter 40 and withdrawcatheter 40 from within the patient's radial artery. In the illustratedembodiment, catheter 40 is depicted as having been withdrawn from accesssite 52 and from the patient's vasculature. Once the catheter tip 49 hasbeen withdrawn from the patient's body, the practitioner can once againrotate rotatable member 12 in a clockwise direction and increase thepressurization provided by compression pad 30 on the access site 52.This provides a desired degree of hemostasis until the access sitecloses and heals sufficiently to prevent further bleeding of the accesssite subsequent to the procedure. As a result, radial artery compressiondevice 10 can provide supplemental pressure at the catheter access pointafter the procedure has been completed rather than requiring a nurse,doctor, or patient from applying pressure until bleeding at the catheteraccess site has diminished or stopped. Additionally, the amount ofpressure can be adjusted. For example, initially a greater amount ofcompression pressure can be provided. After an amount of time, thepressure provided by the radial artery compression device can belessened.

FIG. 3 is a perspective exploded view of radial artery compressiondevice 10 according to one embodiment of the present invention. In theillustrated embodiment, the threaded components of radial arterycompression device 10 are depicted. Threaded shaft 50 is integrallycoupled to compression pad 30. A rotatable member post 54 having threads58 on the outside surface 56 of rotatable member post 54 is depicted.Rotatable member post 54 is integrally coupled to rotatable member 12.Additionally, a center aperture 64 of body 20 is depicted. Centeraperture 64 also includes a plurality of threads 66. Center aperture 64is adapted to engage threads 58 on the outside surface 56 of rotatablemember post 54.

As a practitioner rotates rotatable member 12, threads 58 of rotatablemember post 54 threadably engage threads 66 of center aperture 64. As aresult, as rotatable member 12 is rotated, rotatable member 12 isaxially displaced relative to body 20. Threaded shaft 50 includesthreads 70 on the outside surface of threaded shaft 50. Threads 70 onthe outside surface of threaded shaft 50 are adapted to engage threadspositioned on the inside diameter of rotatable member post 54. Thethreaded engagement of threaded shaft 50 and rotatable member post 54results in displacement of compression pad 30 relative not only to body20, but also to rotatable member 12 pursuant to rotation of rotatablemember 12. The threaded engagement of threaded shaft 50, rotatablemember post 54 and body 20 results in a compounding effect of themovement of compression pad 30 during rotation of rotatable member 12.

When rotatable member 12 is rotated, cooperative engagement betweenrotatable member post 54 and center aperture 64 results in displacementof rotatable member 12 relative to body 20. The engagement betweenthreaded shaft 50 and rotatable member post 54 results in displacementof compression pad 30 relative to body 20. Additionally, the engagementof threaded shaft 50 and rotatable member post 54 results in an amountof displacement of compression pad 30 relative to rotatable member 12.According to one embodiment of the present invention, a first amount ofdisplacement between compression pad 30 and body 20 results upon a firstamount of rotation of rotatable member 12. A second amount ofdisplacement which is different than the first amount of displacementoccurs between compression pad 30 and rotatable member 12 upon the sameamount of rotation of rotatable member 12.

The primary and secondary threaded engagement results in a compoundingeffect pursuant to which rotation of rotatable member 12 results in agreater amount of displacement between compression pad 30 and body 20than the displacement provided between rotatable member 12 and body 20pursuant to a given amount of rotation. For exemplary purposes,according to one embodiment of the present invention, when the rotatablemember is rotated one-half rotation, a change in displacement betweenrotatable member 12 and body 20 of approximately one-quarter inchoccurs. During the one-half rotation of rotatable member 12, a change ofdisplacement between compression pad 30 and body 20 of approximatelyone-half inch occurs. In other words, compression pad 30 movesapproximately twice as far relative to body 20 than rotatable member 12moves relative to body 20 during the same amount of rotation ofrotatable member 12.

In the illustrated embodiment, rotation of rotatable member 12 in aclockwise direction results in movement of rotatable member 12 in thedirection of body 20. The same rotation of rotatable member 12 in theclockwise direction results in a greater amount of displacement betweencompression pad 30 and body 20. In other words, rotation of rotatablemember 12 in a clockwise direction results in downward movement of bothhandle member 14 and compression pad 30. Rotation of rotatable member 12in a counter-clockwise direction results in retraction of compressionpad 30 in the direction of body 20. Additionally, rotation of rotatablemember 12 in a counter-clockwise direction results in a greater amountof displacement between body 20 and rotatable member 12. In other words,rotation of rotatable member 12 in a counter-clockwise direction resultsin upward movement of both compression pad 30 and rotatable member 12.

In the illustrated embodiment, rotatable member posts 60 a, b aredepicted. Rotatable member posts 60 a, b include ramp surfaces 62 a, bon their outward facing surfaces. Ramp surfaces 62 a, b are adapted toengage ramp or notch members provided on the inside diameter ofrotatable member 12. The alignment and orientation of ramp surfaces 62a, b allow rotation of rotatable member 12 in a first direction whilepreventing or minimizing rotation of rotatable member 12 in a seconddirection. When a user desires to rotate rotatable member 12 in thesecond direction, ramp surfaces 62 a, b will inhibit such rotation. Inorder to effectuate rotation of rotatable member 12 in the reversedirection, the user simply grasps ratchet engagement members 26 a, b andurges them in an inward direction. This results in inward lateralmovement of rotatable member engagement posts 60 a, b. The lateralmovement of rotatable member engagement posts 60 a, b causesdisengagement of ramp surfaces 62 a, b from the ratchet members on theinside diameter of rotatable member 12 permitting the rotationalmovement of rotatable member 12 in a second direction.

In the illustrated embodiment, the configuration of ramp surfaces 62 a,b permits rotation of rotatable member 12 in a first direction withoutrequiring the actuation of ratchet engagement members 26 a, b. However,ramp surfaces 62 a, b minimize or prevent the rotational movement ofrotatable member 12 in a counter-clockwise direction absent, or in theabsence of, actuation of ratchet engagement members 26 a, b.

Body engagement posts 72 a, b are provided in connection withcompression pad 30. Body engagement posts 72 a, b are integrally coupledor otherwise secured to compression pad 30. Body engagement posts 72 a,b are adapted to be threaded through lateral apertures 68 a, bpositioned through alternative sides of body 20 and on opposing sides ofcenter aperture 64. Body engagement posts 72 a, b maintain therotational orientation of compression pad 70 relative to the othercomponents of radial artery compression device 10 during rotation ofrotatable member 12. In this manner, a desired alignment of compressionpad 30, and in particular notch 36 and step 38 of compression pad 30,can be maintained notwithstanding the rotational position of rotatablemember 12. Body engagement posts 72 a, b include tabs 74 a, b. Tabs 74a, b are sloped structures which permit the introduction of bodyengagement posts 72 a, b through lateral apertures 68 a, b duringassembly. Additionally, tabs 74 a, b include a shelf member whichinhibits or prevents the accidental removal or passage of bodyengagement posts from their cooperative engagement with body 20.

Body engagement posts 72 a, b also maintain the rotational orientationof threaded shaft 50. As a result, rotation of rotatable member post 54pursuant to rotation of rotatable member 12 results in movement ofthreads 58 of rotatable member post 54 in relation to threads 70 ofthreaded shaft 50. Rotation of rotatable member post 54 results in axialmovement of threaded shaft 50 and compression pad 30 relative torotatable member post 54. As rotatable member 12 is rotated, rotatablemember post 54 also rotates. During rotation of rotatable member post54, the rotational orientation of body 20, threads 66 of center aperture64, compression pad 30 and threads 70 of threaded shaft 50 remainsfixed. As a result, threaded shaft 50, compression pad 30, rotatablemember post 54 and rotatable member 12 are displaced axially relative tobody 20 pursuant to rotation of rotatable member 12 and rotatable memberpost 54.

The juxtaposition of rotatable member post 54 relative to centeraperture 64 and threaded shaft 50 relative to rotatable member post 54also helps to minimize rotational forces which may urge compression pad30 to a different rotational position other than the one desired. In theillustrated embodiment, recess 22 is illustrated. Recess 22 comprises acutout or spaced gap type member on the underside of body 20. Recess 22is sized to receive compression pad 30 when compression pad 30 isretracted to its position closest to body 20. In other words, whencompression pad 30 is fully retracted relative to body 20, all or aportion of compression pad 30 is positioned within recess 22.

In the illustrated embodiment, handle member 14 is provided inconnection with rotatable member 12. The shape of handle member 14allows a user to place a thumb and index finger on alternative sides ofhandle member 14 to twist rotatable member 12 in either a clockwise orcounter-clockwise rotational direction. The arcuate configuration ofhandle member 14 creates a concave surface 77 and convex surface 78 oneach lateral side of handle member 14. For example, the concave portion77 of lateral side 76 of handle member 14 is on the opposing side of aconvex portion on the other lateral side of the handle member 14.Similarly, the convex portion 78 on the lateral side 76 is on theopposing side of the concave portion of the opposing lateral side of thehandle member 14. In this manner, an ergonomic and easy to graspconfiguration is provided by handle member 14.

As will be appreciated by those skilled in the art, a variety of typesand configurations of radial artery compression devices can be providedwithout departing from the scope and spirit of the present invention.For example, according to one embodiment of the present invention, amechanism other than a ratchet engagement member is provided to securethe rotational position of the rotatable member. According to anotherembodiment of the present invention, a ratchet engagement member isprovided only on one side of the rotatable member. According to anotherembodiment of the present invention, the rotational position of thecompression pad is secured relative to the body utilizing a mechanismother than the body engagement post. According to another embodiment ofthe present invention, rotation of the rotatable member results inmovement of the compression pad utilizing a single set of threads.According to yet another embodiment of the present invention, rotationof the rotatable member only results in movement of the compression padrelative to the body and does not cause movement of the rotatable memberrelative to the body.

FIG. 4A is a side view of radial artery compression device 10 of FIG. 1according to one embodiment of the present invention. In the illustratedembodiment, compression pad 30 is illustrated in a fully extendedposition. When compression pad 30 is in a fully extended position, thedisplacement between compression pad 30 and body 20 is maximized.Additionally, when compression pad 30 is in a fully extended position,rotatable member 12 is positioned at a displacement that is closer tobody 20 than at any other rotational position of rotatable member 12.

Rotatable member engagement posts 60 a, b are positioned in cooperativeengagement with the inside diameter of rotatable member 12. When a userdesires to rotate rotatable member 12 in a counter-clockwise directionto permit the retraction of compression pad 30, a user simply depressesratchet engagement members 26 a, b toward one another. Depressing ofratchet engagement members 26 a, b results in manipulation of a portionof body 20 coextensive with rotatable member engagement posts 60 a, b.As a result, the cooperative engagement provided in connection with rampsurfaces 62 a, b (see FIG. 3) is broken permitting rotational movementof rotatable member 12 in a counter-clockwise direction.

In the illustrated embodiment, the juxtaposition of threaded shaft 50relative to rotatable member post 54 is depicted. Threads 70 of threadedshaft 50 are cooperatively engaged with threads that are positioned onthe inside diameter of rotatable member post 54. As a result, whenrotatable member 12 is rotated, rotation of rotatable member post 54results in axial movement of compression pad 30 due to the interactionbetween threads 70 of threaded shaft 50 and the threads on the insidediameter of rotatable member post 54. Additionally, the engagementbetween threads 58 on the outside surface 56 of rotatable member post 54results in movement of rotatable member post 54 relative to body 20.Threads 58 of rotatable member post 54 cooperatively engage threads 66of center aperture 64 (see FIG. 3). As a result, movement of compressionpad 30 results not only from the engagement of threaded shaft 50 withrotatable member post 54, but also the cooperative engagement ofrotatable member post 54 with body 20. The engagement of the componentsof threaded shaft 50, rotatable member post 54 and center aperture 64cause a compounding of the axial displacement of compression pad suchthat a given amount of axial displacement of rotatable member 12relative to body 20 results in a greater amount of axial displacement ofcompression pad 30 relative to body 20 than would be provided by asingle threaded interaction.

Compression pad 30 includes a first portion 32 and a second portion 34.First portion 32 is positioned on one side of step 38 and second portion34 is positioned on the opposing side of step 38. First portion 32includes an interior surface 80 a and a contact surface 82 a. Secondportion 34 includes an interior surface 80 b and a contact surface 82 b.Additionally, first portion 32 includes a sidewall 84 a and secondportion 34 includes a sidewall 84 b. In the illustrated embodiment, thedisplacement between interior surface 80 a and contact surface 82 a hasa smaller amount of displacement than the displacement between interiorsurface 80 b and contact surface 82 b of second portion 34. In otherwords, sidewall 84 a of first portion 32 is smaller or has a smallerheight than the height of sidewall 84 b of second portion 34. Thediffering heights of sidewall 84 a and 84 b are adapted such that theelevation of contact surface 82 a of first portion 32 is different fromthe elevation of contact surface 82 b of second portion 34.

The differing elevations of contact surface 82 a and 82 b allows thecontact surfaces of compression pad 30 to conform to a patient's wrist.As a result, contact surface 82 b of second portion 34 can be positionedon the outside of the patient's wrist while contact surface 82 a offirst portion 32 can be positioned toward the inner part of thepatient's wrist. In this manner, a consistent and desired amount ofcontact between most or all of compression pad 30 can be maintainedrelative to the patient's wrist, notwithstanding the elevational changesand the physiological features of a typical patient's wrist.

Step 38 is adapted to be positioned over the patient's artery. Step 38includes a contact surface 86 which runs along the length of step 38. Inthe illustrated embodiment, contact surface 86 has a curvilinear orarcuate configuration which is adapted to somewhat conform to thecurvilinear outside diameter of a typical catheter or to the roundedconfiguration of the outside diameter of the patient's radial artery. Inthis manner, when a catheter is positioned within the patient's radialartery, a desired cooperative contact can sandwich the outside diameterof the patient's radial artery between the catheter and the patient'sbody tissues as a result of the compression provided by the contactsurface 86 of step 38.

In the illustrated embodiment, when compression pad 30 is positioned atits fully extended position, a maximum amount of displacement betweencontact surface 82 a and contact surface 82 b is provided relative tothe underside of recess 22. In other words, when compression pad 30 isin its fully extended position, contact surfaces 82 a and 82 b are alsopositioned at their furthest displacement relative to body 20. As aresult, when compression pad 30 is at a fully extended position amaximum amount of compression can be provided when radial arterycompression device 10 is secured to a patient's wrist.

As will be appreciated by those skilled in the art, a variety of typesand configurations of radial artery compression devices can be providedwithout departing from the scope and spirit of the present invention.For example, according to one embodiment of the present invention, theextension of the compression pad is the result not only of the rotationof the rotatable member, but also of other operating components of theradial artery compression device. According to another embodiment of thepresent invention, the extension of the compression pad is only one oftwo or more components that are utilized to exert pressure on apatient's radial artery or other physiological feature. According toanother embodiment of the present invention, the compression pad has afirst rigid component and a second flexible component whichcooperatively engage the patient's radial artery or catheter. Accordingto yet another embodiment of the present invention, the shape,configuration or material properties of the relief surface or contactsurfaces of the compression pad can vary.

FIG. 4B is a side view of the radial artery compression device 10illustrating compression pad 30 in a fully retracted position. In theillustrated embodiment, when compression pad 30 is in a fully retractedposition, rotatable member 12 is positioned at a maximum amount of axialdisplacement relative to body 20. When compression pad 30 is in a fullyretracted position, compression pad 30 is fully or partially retractedwithin recess 22. In the illustrated embodiment, it can be seen thatwhen compression pad 30 is in a fully retracted position, bodyengagement posts 72 a, b extend above the upper surface of body 20.

As will be appreciated by those skilled in the art, to move compressionpad 30 from the fully extended position depicted in FIG. 4A, to thefully retracted position depicted in FIG. 4B, the user rotates rotatablemember 12 in a counter-clockwise direction. To rotate the rotatablemember 12 in a counter-clockwise direction, the user actuates ratchetengagement members 26 a, b disengaging rotatable member engagement posts60 a, b relative to rotatable member 12 and permitting rotation ofrotatable member in a counter-clockwise direction. As the user rotatesrotatable member 12 in a counter-clockwise direction, compression pad 30is retracted in the direction of body 20. The configuration of rotatablemember 12 and the other components of radial artery compression 10device allows for varying amounts of displacement between compressionpad 30 and body 20. In this manner, varying degrees of compression canbe provided by radial artery compression device 10, depending on theparticular requirements of the procedure being performed and/or howtightly radial artery compression device 10 is secured relative to thepatient. Additionally, the practitioner can rotate rotatable member 12to incrementally change the degree of extension of compression pad 30throughout the course of the procedure to adjust the amount ofcompression provided by radial artery compression device 10.

In the illustrated embodiment, interior surfaces 80 a, b are positioneddirectly adjacent or in contact with body 20. Additionally, all or apart of sidewalls 84 a, b are retracted within recess 22. As will beappreciated by those skilled in the art, compression pad 30 can be fullyretracted in recess 22 at the beginning of a procedure beforecompression pad 30 has been actuated. Similarly, compression pad 30 canbe fully retracted into recess 22 at the end of a procedure after acatheter has been withdrawn from the patient. Compression pad 30 canalso be retracted into recess 22 at any point during the course of theprocedure when a practitioner desires to reposition the radial arterycompression device or otherwise release pressure from the patient'svasculature.

In the illustrated embodiment, when compression pad 30 is retracted intorecess 22, rotatable member post 54 has been rotated such that thebottom of rotatable member post 54 is fully retracted within body 20.Additionally, the portion of threaded shaft 50 positioned adjacentcompression pad 30 has been fully retracted to within body 20. As aresult, when compression pad 30 is fully retracted within body 20, theoverall elevational profile from the top of handle member 14 to thebottom of compression pad 30 is at its smallest. Or in other words, thedisplacement between the top of handle member 14 and the bottom ofcompression pad 30 is at its smallest when compression pad 30 is fullyretracted to within body 20. In contrast, when compression pad 30 is atits fully extended position, the displacement between the top of handlemember 14 and the bottom of compression pad 30 is at its greatestdisplacement. The relative change in displacement between the top ofhandle member 14 and the bottom of compression pad 30 at the differentrotational positions of rotatable member 12 is a result of the compoundmovement of compression pad 30 relative to body 20 provided by themultiple threaded engagements between threaded shaft 50, rotatablemember post 54, and center aperture 64 (see FIG. 3).

In the illustrated embodiment the underside of rotatable member 12 isconfigured to accommodate the top of body engagement post 72 a, b. Thispermits the desired axial movement of body engagement post 72 a, b ascompression pad 30 moves in the direction of rotatable member 12 and inspite of the compounded axial displacement of compression pad 30resulting from the cooperative engagement of threaded shaft 50,rotatable member post 54 and center aperture 64.

As will be appreciated by those skilled in the art, a variety of typesand configurations of radial artery compression devices can be provided.According to one embodiment of the present invention, a single threadedengagement is provided between the components of the radial arterycompression device. According to another embodiment of the presentinvention, four or more threaded engagements are provided in connectionwith the components of the radial artery compression device to providefurther compounding of the axial movement of one or more components ofthe radial artery compression device. According to another embodiment ofthe present invention, the rotational position of the compression pad ismaintained in place utilizing a mechanism other than body engagementpost. According to yet another embodiment of the present invention, thebody engagement post comprises a uniform outer wall around most or allof the outer circumference of the compression pad. According to yetanother embodiment of the present invention, movement of the compressionpad is provided in a linear fashion rather than a compounding fashion asdepicted in FIG. 4B.

FIG. 5 is a bottom perspective view of the radial artery compressiondevice of the present invention. In the illustrated embodiment, theinternal configuration of the rotatable member 12 can be seen. Rotatablemember 12 includes a recess 90 which is positioned on an inner diameterof sidewall 16. Recess 90 is adapted to accommodate rotatable memberengagement post 60 a, b (see FIG. 3).

Recess 90 is coextensive with an inside diameter of sidewall 92, ramps94, and an interior wall 96. In the illustrated embodiment, the insidediameter of sidewall 92 includes a plurality of ramps 94. Ramps 94 areone example of a ratchet mechanism which are adapted to engage rampssurfaces 62 a, b of rotatable member engagement post 60 a, b (see FIG.3). The configuration of ramps 94 permits rotational movement ofrotatable member 12 in a first direction while controlling rotation ofrotatable member 12 in a second direction. In other words, thepractitioner can rotate rotatable member 12 in one direction withoutactuating ratchet engagement members 26 a, b. To freely rotate rotatablemember 12 in a second direction, the practitioner actuates ratchetengagement members 26 a, b. For example, according to one embodiment ofthe present invention, the practitioner is allowed to rotate rotatablemember 12 in a clockwise direction as depicted in FIG. 2B withoutactuating ratchet engagement members 26 a, b. However, the practitioneractuates ratchet engagement members 26 a, b in order to rotate rotatablemember 12 in a second direction as depicted in FIG. 2C.

In the illustrated embodiment, rotatable member 12 includes a bottomcontact surface 98. When rotatable member 12 is rotated such thatcompression pad 30 is fully extended, bottom contact surface 98 ispositioned adjacent to and in contact with body 20. When thepractitioner rotates rotatable member 12 in a second direction such thatcompression pad 30 is fully retracted into body 20 as depicted in FIG.4B, a desired amount of displacement is provided between bottom contactsurface 98 and body 20. In other words, when compression pad 30 is fullyretracted, a greater amount of displacement is provided betweencompression pad 30 and body 20 than is provided between rotatable member12 and body 20. When compression pad 30 is fully retracted, a greateramount of displacement is provided between rotatable member 12 and body20 than is provided between compression pad 30 and body 20.

As will be appreciated by those skilled in the art, a variety of typesand configurations of radial artery compression devices can be providedwithout departing from the scope and spirit of the present invention.For example, in one embodiment only the handle member of the radialartery compression device rotates. In this embodiment, the sidewallremains fixed in its rotational orientation while interior componentsrotate pursuant to rotation or other actuation of a handle member,button or other actuation mechanism.

According to one aspect of the present invention, ramps 94 may bepositioned on interior wall 96 so as to permit rotation of the handlemember 14 in a first direction but to prevent rotation of the handlemember 14 in a second direction. Rotatable member engagement post 60 a,b (see FIG. 4B) are directed to engage ramps 94 which would bepositioned on the interior wall 96 associated with handle member 14.According to another aspect of the present invention, actuation ofratchet engagement member 26 a not only biases the portion of body 20associated with rotatable member engagement posts 60 a, b (see FIG. 4B),but causes the mechanical movement of the post pursuant to secondarymechanical members such as a spring, a leaf spring, biasing member orother actuatable components.

FIG. 6A is a side cutaway view of radial artery compression device 10according to one embodiment of the present invention. In the illustratedembodiment, threads 66 of center aperture 64 are illustrated andcompression pad 30 is shown in a fully extended position. Whencompression pad 30 is in a fully extended position, interior surfaces 80a, b are positioned a given amount of displacement from the underside ofrecess 22. In other words, a maximum amount of displacement betweencontact surfaces 82 a, b and body 20 is provided when compression pad 30is in a fully extended position. Additionally, only the upper portion ofbody engagement posts 72 a, b are positioned within recess 90 ofrotatable member 12.

When compression pad 30 is in a fully extended position, bottom contactsurface 98 of rotatable member 12 is positioned in contact with body 20.Ramps 94 on the inside diameter of sidewall 92 cooperatively the engageramp surfaces of rotatable member engagement posts 60 a, b. Thecooperative engagement between the ramp surfaces of rotatable engagementposts 60 a, b and ramps 94 permit rotation of rotatable member 12 untilcompression pad 30 is fully extended. Once compression pad 30 is in apartially or fully extended position, engagement between the rampsurfaces of rotatable engagement posts 60 a, b and ramp 94 prevent orminimize rotation of rotatable member 12 in a rearward direction unlessthe practitioner depresses ratchet engagement members 26 a, b.

As the practitioner rotates rotatable member 12, rotatable member post54 is also rotated as a result of the integral coupling betweenrotatable member 12 and rotatable member post 54. As rotatable memberpost 54 is rotated, threads 58 of rotatable member post 54 engagethreads 66 of center aperture 64. The threaded engagement betweenthreads 58 and 66 displaces rotatable member 12 relative to body 20.Additionally, rotation of rotatable member 12 and rotatable member post54 results in engagement of threads 70 by threads 100 on the insidediameter of rotatable member post 54. In this manner, rotation ofrotatable member 12 provides interactive forces which result in theaxial displacement of compression pad 30 relative to rotatable member12. Axial displacement of rotatable member 12 relative to compressionpad 30 is a result of the interaction between threads on the insidediameter of center aperture 64, threads on the outside diameter ofrotatable member post 54, threads on the inside diameter of rotatablemember post 54, and threads on the outside diameter of threaded shaft50. The cooperative engagement of these threads results in a compoundingof the axial movement of compression pad 30 relative to body 20.

In the illustrated embodiment, rotatable member post is positioned suchthat the portion of rotatable member post 54 adjacent rotatable member12 has been substantially advanced into body 20. The bottom or distalmost extent of rotatable member post 54 extends below body 20 such thatthe distal extent of rotatable member post extends below recess 22 andwrist strap securement members 24 a, b. Threaded shaft 50 has beenextended a given amount such that the portion of threaded shaft 50 whichis positioned adjacent to compression pad 30 extends outside ofrotatable member post 54. The cooperative engagement of threaded shaft50, rotatable member post 54 and center aperture 64, results incompounding of the axial movement of compression pad 30 relative to body20 when rotatable member 12 is rotated by a practitioner.

FIG. 6B illustrates radial artery compression device 10 in whichcompression pad 30 is in a fully retracted position. In the illustratedembodiment, when compression pad 30 is in a fully retracted position,contact surface 82 a is aligned with the portion of wrist strapsecurement member 24 a positioned adjacent compression pad 30. In otherwords, the portion of compression pad 30 positioned adjacent wrist strapsecurement member 24 a is fully retracted to within recess 22. Contactsurface 82 b is positioned adjacent wrist strap securement member 24 b.Contact surface 82 b extends a certain amount of displacement belowwrist strap securement member 24 b. This is due to the fact that contactsurface 82 b has a lower elevation than contact surface 82 a. It will beappreciated that the configuration of the contact surfaces ofcompression pad 30 and the amount to which compression pad 30 iswithdrawn into a recess of body 20 can vary depending on the size of therecess, the thickness of the compression pad, or other variables relatedto the components of the radial artery compression device that can beselected according to the particular requirements of a compressionprocedure to be performed.

In the illustrated embodiment, when compression pad 30 is fullyretracted within recess 22, rotatable member 12 is positioned at itsgreatest displacement from body 20. Bottom contact surface 98 ispositioned at a given amount of displacement from the portion of body 20positioned opposite bottom contact surface 98. Body engagement posts 72a, b are fully retracted such that a substantial portion of bodyengagement posts 72 a, b extend above body 20. When compression pad 30is fully retracted to within body 20, the portion of body engagementposts 72 a, b associated with tab 74 a, b extend higher than rotatablemember engagement posts 60 a, b. As a result, a portion of bodyengagement posts 72 a, b are positioned within recess 90.

In the illustrated embodiment, a substantial portion of rotatable postmember 54 is positioned above body 20. Additionally, the bottomextremity of rotatable member post 54 is retracted such that it ispositioned within body 20. Similarly, when compression pad 30 is fullyretracted to within body 20, threaded shaft 50 is retracted to aposition within body 20 such that the portion of threaded shaft 50adjacent compression pad 30 has been retracted to within body 20 whilethe upper extremity of threaded shaft 50 extends above body 20. In thedepicted configuration, the entire portion of threaded shaft 50 ispositioned within rotatable member post 54. In other words, the upperextent of the threaded shaft 50 and the lower extent of the threadedshaft 50 are positioned such that substantially the entire length of thethreaded shaft 50 is positioned within the inner cavity of the rotatablemember post 54. Rotatable member post 54 is an example of a firstthreaded shaft. Threaded shaft 50 is an example of a secondary threadedshaft.

In the illustrated embodiment, rotatable member 12 has been displacedrelative to body 20. In other words, a determined amount of displacementis provided between rotatable member 12 and body 20 when compression pad30 is fully retracted to within body 20. As a result, only the bottomportion of inside diameter of sidewall 92 contacts ramp surfaces ofrotatable member engagement post 60 a, b. This is in contrast to theengagement of rotatable member engagement post 60 a, b withsubstantially the entire length of the inside diameter of sidewall 92when compression pad is fully extended as depicted in FIG. 6A.

As will be appreciated by those skilled in the art, of a variety oftypes and configurations of the internal components of the radial arterycompression device can be utilized without departing from the scope andspirit of the present invention. For example, according to oneembodiment of the present invention, the threaded engagement between thecomponents associated with the compression pad, the body, and therotatable member can occur on the outside diameter of those componentsrather than internally or on an inside radius of the rotatable member.According to another embodiment of the present invention, the threadedshaft associated with the rotatable member can be placed on the insidediameter while the rotatable member associated with the compression padcan be positioned on the outside of the threaded member of the rotatablemember.

FIG. 7 is a perspective view of a patient's radial artery 102 accordingto one aspect of the present invention. In the illustrated embodiment, across-section of the patient's wrist 41 is depicted. The cross-sectionof the patient's wrist shows the approximate position of a catheterthreaded through radial artery 102 of the patient. Radial artery 102 hasan outside diameter which is substantially circumferential in naturesuch that the portion of radial artery 102, which is positioned to be incontact with contact surface 86 of step 38, largely conforms to thearcuate configuration of contact surface 86 of step 38.

A catheter 40 is positioned within radial artery 102 of the patient.Compression provided by compression pad 30 ensures that a desired amountof pressure is provided on radial artery 102. As a result, the innerdiameter of radial artery 102 is positioned directly adjacent to and incontact with the outside diameter of catheter 40. In this manner, thetissue surrounding radial artery 102 provides sufficient contact betweenthe outside diameter of catheter 40 and in the inside diameter of radialartery 102 to provide a desired degree of hemostasis so as to preventbleeding or the leakage of fluid at the radial artery access site.

In the illustrated embodiment, the alignment of notch 36 relative tocatheter 40 is depicted. Notch 36 enables positioning of compression pad30 such that the radial artery access site is positioned directly belowthreaded shaft 50. Aligning the radial artery access site directly belowthreaded shaft 50 allows the compressive or axial forces provided bythreaded shaft 50 to be applied directly to the radial artery accesssite without interruption from catheter 40. In other words, compressionpad 30 can apply pressure to the patient without catheter 40 beingthreaded underneath a contact surface of compression pad 30 on theoutside radius of compression pad 30. In this manner, the catheter 40can be threaded through notch 36 to a more central portion ofcompression pad 30 such that catheter 40 does not result in obstructionor tilting of compression pad 30. As a result, direct pressure can beapplied to the radial artery catheter access site by the portion ofcompression pad 30 associated with threaded shaft 50.

FIG. 8 is a top perspective view of a radial artery compression device10 according to one embodiment of the present invention. In theillustrated embodiment, rotatable member 12 of radial artery compressiondevice 10 provides visual access to the access site 52 of catheter 40.In this manner, a practitioner can approximately visualize thejuxtaposition of radial artery compression device 10 relative to accesssite 52.

In the depicted embodiment, rotatable member 12 includes a central void17. Central void 17 comprises a recess portion adjacent handle member14. Central void 17 is intersected by the arcuate configuration ofhandle member 14. In other words, handle member 14 extends from onelateral side of central void 17 to the opposing lateral side of centralvoid 17. In this manner, a recess is provided relative to upper face 18of rotatable member 12. Handle member 14 can extend from an elevationwhich extends above upper face 18 to a position within central voidwhich extends below upper face 18. The resultant hemispherical typevoids on either lateral side of handle member 14 created by thejuxtaposition of central void 17 and handle member 14 can receive thefinger or thumb to grasp handle member 14 and cause rotation ofrotatable member 12.

A floor surface 110 is provided in connection with central void 17.Floor surface 110 is transparent, translucent or otherwise less thanopaque allowing a practitioner to see access site 52, catheter 40, orother objects or surfaces positioned on the underside of radial arterycompression device 10. In this manner, a practitioner can ascertain thejuxtaposition of radial artery compression device 10 relative to thepatient's wrist, catheter 40, access site 52 or another object orsurface. The practitioner can thus adjust the positioning of thecompression pad or components of the compression pad relative to theaccess site 52. As will be appreciated by those skilled in the art, inorder for a practitioner to be able to visualize the access site, othercomponents of radial artery compression device may also be comprised ofa clear, transparent, translucent or otherwise visually transductivematerial. For example, the compression pad, rotatable member post andany one or more components of the radial artery compression device 10may be formed of a transparent or translucent material. According toanother embodiment of the present invention a plurality of components orall of the components of the radial artery compression device are formedof a visually transductive material. Floor surface 110 is one example ofa viewing window.

As will be appreciated by those skilled in the art, a variety of typesand configurations of compression devices can be provided withoutdeparting from the scope and spirit of the present invention. Forexample, according to one embodiment of the present invention, a cavityor oversized recess can be provided in place of a notch on thecompression pad to allow for clearance of the catheter from the bottomof the radial artery compression device. According to another embodimentof the present invention, the step has a shape other than an arcuate,radius, or circumferential contact surface which is adapted to provide adesired contact between the compression pad and the patient. Accordingto another embodiment of the present invention, the radial arterycompression device is a compression device utilized with a portion ofthe patient's body other than the radial artery. For example, in oneembodiment of the present invention, the compression device comprises afemoral compression device which is sized and shaped to be positionedover and provide pressure to a patient's femoral artery. According toanother embodiment of the present invention, the compression device isadapted to provide pressure both during the course of a procedure andupon completion of a procedure. According to yet another embodiment ofthe present invention, the compression device is adapted to be utilizedwith a plurality of compression pads which can be positioned on opposingsides of a patient's limb, adjacent multiple access sites, as desired bythe practitioner, or as required by particular aspects of the procedureto be performed.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. A radial artery compression device, the radial artery compressiondevice adapted to allow a user to provide varying degrees ofpressurization against a patient's radial artery to maintain a desireddegree of hemostasis at a percutaneous access site, the radial arterycompression device comprising: a body; a rotatable member positionedadjacent the body such that the rotatable member can be rotated relativeto the body; a compression pad operably coupled to the rotatable member;a threaded shaft formed of rigid material and disposed through the body,the threaded shaft being positioned between the body and the compressionpad, the threaded shaft configured to move the compression pad withrespect to the body as the rotatable member is rotated relative to thebody such that rotation of the rotatable member does not affect therotational orientation of the compression pad; and a securement memberadapted to secure the position of the body relative to the portion of apatient's wrist corresponding with the radial artery, such that rotationof the rotatable member in a first direction is adapted to increase theamount of compression applied to the radial artery by the compressionpad, and rotation of the rotatable member in a second direction isadapted to decrease the amount of compression applied by the radialartery to the compression pad.
 2. The radial artery compression deviceof claim 1, further comprising a secondary threaded shaft.
 3. The radialartery compression device of claim 2, wherein the secondary threadedshaft is integrally coupled to the compression pad.
 4. The radial arterycompression device of claim 1, wherein the threaded shaft is securelycoupled to the rotatable member such that rotation of the rotatablemember causes rotation of the threaded shaft.
 5. The radial arterycompression device of claim 2, wherein the secondary threaded shaftthreadably engages the threaded shaft.
 6. The radial artery compressiondevice of claim 5, wherein the threaded shaft includes threads on theoutside diameter of a wall of the threaded shaft and threads on theinside diameter of a wall of the threaded shaft.
 7. The radial arterycompression device of claim 6, wherein the secondary threaded shaftengages the threads on the inside diameter of the wall of the threadedshaft.
 8. The radial artery compression device of claim 6, wherein thethreads on the outside diameter of the wall of the threaded shaftthreadably engage the body.
 9. The radial artery compression device ofclaim 1, further comprising body engagement posts secured to thecompression pad to secure the rotational orientation of the compressionpad during rotation of the rotatable member.
 10. A radial arterycompression device comprising: a body; a rotatable member positionedadjacent the body such that the rotatable member can be rotated relativeto the body; a compression pad; a threaded shaft formed of rigidmaterial and disposed through the body, the threaded shaft beingpositioned between the body and the compression pad, the threaded shaftconfigured to move the compression pad with respect to the body as therotatable member is rotated relative to the body; and a compression padsecurement mechanism adapted to allow a practitioner to increase theamount of compression provided by the compression pad, but controlmovement of the compression that would decrease the amount ofcompression provided by the compression pad to allow a practitioner toapply a desired degree of compression utilizing the radial arterycompression device in a consistent manner to minimize the inadvertent orundesired removal of the desired degree of compression during the courseof a procedure.
 11. The radial artery compression device of claim 10,wherein the user actuates a component of the compression pad securementmember to lessen the amount of compression provided by the compressionpad.
 12. The radial artery compression device of claim 10, wherein thecompression pad securement member controls rotation of the rotatablemember.
 13. The radial artery compression device of claim 12, whereinthe compression pad securement member permits rotation of the rotatablemember in a first direction but controls rotation of the rotatablemember in a second direction.
 14. The radial artery compression deviceof claim 13, wherein the compression pad securement member comprises arotatable member securement device having a ratchet mechanism whichpermits rotation of the rotatable member in a first direction butcontrols rotation of the rotatable member in a second direction.
 15. Theradial artery compression device of claim 14, wherein rotatable membersecurement device comprises ratchet engagement members which permitrotation of the rotatable member in a first direction but controlrotation of the rotatable member in a second direction such that a useractuates the ratchet engagement members to permit rotation of therotatable member in the second direction.
 16. A radial arterycompression device, the radial artery compression device adapted toallow a user to provide varying degrees of pressurization against apatient's radial artery to maintain a desired degree of hemostasis at apercutaneous access site, the radial artery compression devicecomprising: a body; a rotatable member positioned adjacent the body suchthat the rotatable member can be rotated relative to the body; acompression pad operably linked to the rotatable member; a shaft beingpositioned between the rotatable member and the compression pad, theshaft threadably engaging the body to move the rotatable member relativeto the body; and a second shaft being positioned between the rotatablemember and the compression pad, wherein engagement between the firstshaft and the second shaft causes a compounding of the amount ofcompression provided by the compression pad.
 17. The radial arterycompression device of claim 16, wherein rotation of the rotatable memberresults in axial movement of the rotatable member towards or away fromthe body.
 18. The radial artery compression device of claim 17, whereinthe rotation of the rotatable member results in axial movement of thecompression pad towards or away from the body.
 19. The radial arterycompression device of claim 18, wherein the compounding of the amount ofcompression results in a greater amount of axial movement of thecompression pad relative to the body pursuant to a predetermined amountof rotation of the rotatable member than the amount of axial movement ofthe rotatable member relative to the body pursuant to the predeterminedamount of rotation of the rotatable member.
 20. The radial arterycompression device of claim 19, wherein the compression pad includes athreaded member.
 21. The radial artery compression device of claim 20,wherein the threaded member of the compression pad is threadably engagedby the shaft being positioned between the rotatable member and thecompression pad.
 22. The radial artery compression device of claim 21,wherein one of the threaded shaft and the threaded member threadablyengages a threaded aperture positioned through the body.
 23. The radialartery compression device of claim 21, wherein the threaded member ofthe compression pad comprises a threaded shaft.
 24. The radial arterycompression device of claim 16, further comprising a viewing window. 25.The radial artery compression device of claim 24, wherein the viewingwindow is positioned within a central void of the rotatable member.